Relapse Prevention in Patients With a Major Depressive Episode Treated With Electroconvulsive Treatment Using a Fixed Dose Range of Escitalopram Compared to a Fixed Dose of Nortriptyline (DUAG-7) A Randomised Controlled 6 Month Double-blind Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Hamilton depression rating scale
研究概览
简要总结
The main purpose of this study is to investigate the relapse preventing efficacy of escitalopram in a dose range and nortriptylin in a single dose in patients having been treated successfully with a course of electroconvulsive treatment (ECT).
详细描述
This study records severity of depression and relapse in patients treated for a major depressive disorder with electroconvulsive treatment (ECT)in a period og 6 month after end of ECT treatment. Patients will be randomized into four groups treated with escitalopram 10 mg, 20 mg, 30 mg or nortriptylin 100 mg daily dosages. The primary outcome measure is relapse and secondary outcome measure is tolerability.
The study is a multicenter trial within Denmark.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Remission from a major depressive episode after ECT treatment
排除标准
- •Suicidality (Hamilton item 3 score of 3 or more)
- •Symptoms mania (MAS score of 15 or more)
- •Duration of actual depressive episode more than 2 years
- •Compulsory measures of any kind
- •Severe somatic illness
- •Pregnant or lactating subject
- •Known clinical relevant malabsorption.
- •Epilepsia
- •Clinically substantial cognitive deterioration due to ECT treatment
- •schizophrenia, schizopreniform or schizo-affective disorder
- •Bipolar I, Bipolar II eller
- •Rapid cycling bipolar disorder
- •Abuse of alcohol or drugs
- •Early relapse (less than 2 month) after ECT
- •Inadequate contraception
- •Known intolerance to any of the used study medications
- •Myocardial infarction in the last 6 month
- •Clinical important liver disease
- •Any known disturbance of the cardiac conduction system, cardiac insufficiency,or other clinical important cardiac disease
- •Treatment with a MAO-inhibitor
- •Treatment with norepinephrine or epinephrine
- •Known hyperthyroidism or treatment with thyroid hormones
- •Known ortostatic hypertension.
- •Known hereditary galactoseintolerance, Lapp Lactase deficiency) or gluco-se/galactosemalabsorption.
- •Ongoing treatment with sympatomimetica efedrine, isoprenaline, physostigmine, dopamine, levodopa, phenylephrine.
- •Ongoing treatment with anticholinergica, antiparkinson treatment, antihistamines, atropine, biperiden,
- •Ongoing treatment with drugs that prolongs the cardiac QT-interval, such as quinidine, antihistamines, terfenadine og sotalole
- •Ongoing treatment with fluconazole or terbinafine
- •Ongoing treatment with mefloquin.
- •Known intolerance to escitalopram
- •Ongoing treatment with serotonergic acting substances such as tramadole, sumatriptane
研究组 & 干预措施
Escitalopram 10 mg daily
Escitalopram 10 mg daily
干预措施: escitalopram (Drug)
Escitalopram 20 mg daily
Escitalopram 20 mg daily
干预措施: escitalopram (Drug)
escitalopram 30 mg daily
escitalopram 30 mg daily
干预措施: escitalopram (Drug)
Nortriptylin 100 mg daily
Nortriptylin 100 mg daily
干预措施: nortriptyline (Drug)
结局指标
主要结局
Hamilton depression rating scale
时间窗: 14 days
次要结局
- Drop out due to side-effects of drugs(14 days)
研究者
Klaus Martiny
Senior Consultant
Hillerod Hospital, Denmark